For Immediate Release: August 13, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

  • As part of the FDA’s effort to protect consumers, on August 10, the agency issued a warning letter to Secret of the Islands for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
  • A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for emergency use to prevent COVID-19 in people 12 and older. The CDC recommends COVID-19 vaccination for everyone 12 and older.
  • On Thursday, FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This action does not apply to people who are not immunocompromised.
  • FDA’s vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.
  • Testing updates:
    • As of today, 402 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 87 antibody and other immune response tests and 33 antigen tests. There are 56 molecular authorizations and one antibody authorization that can be used with home-collected samples. There are two molecular prescription at-home test, three antigen prescription at-home tests, six antigen over-the-counter (OTC) at-home tests and three molecular OTC at-home tests.
    • The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 602 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.